Associate Director, International Regulatory Affairs
Incyte
18 days ago
Remote friendly (Wilmington, DE)
United States
Corporate Functions
Job Summary (Primary Function)
- The Associate Director, International Regulatory Affairs develops regulatory strategies with multi-functional teams and partners and ensures International Regulatory Requirements for assigned products are complete.
- Coordinates day-to-day preparation of regulatory submissions and creates regulatory submission documents compliant with International Regulatory Requirements.
- Co-leads meetings with International Health Authorities with the International Regulatory Affairs Lead.
Key Responsibilities
- Align and coordinate with Global Multi-functional Team, International Business Unit, Alliance Management, Regional, and Country leads.
- Prepare regulatory dossiers with technical, preclinical, and clinical data for regulatory approvals.
- Direct activities of and interact with contract research organizations and/or distribution partners for dossier preparation.
- Maintain archival records of submissions and health authority contacts; ensure compliance with company policies and train partners as needed.
- Coordinate responses to health authority questions/inquiries; ensure regulatory maintenance submissions (e.g., Renewals, Annual Reports) are completed on schedule.
- Communicate with health authorities (phone, virtual, in-person).
- Present data clearly and succinctly to support regulatory review.
- Coordinate regulatory review and preparation of documents from all company areas.
- Work with Global Liaisons on submission content, strategy, and timelines.
- Advise development teams on unique scientific/regulatory requirements in targeted regions.
- Review submission materials for timeliness, accuracy, completeness, and regulatory standards compliance.
- Manage creation/review/submission of Orphan Designations, Priority Review Applications, GMP Certifications, HA Meeting Requests, and Marketing Authorizations; evaluate requirements for approval and commercialization.
- Provide regulatory strategies for marketing/life-cycle applications (and may support clinical trial applications/expanded access programs).
- Research international regulations/guidance and recommend impacts to project teams.
Qualifications
- Strong knowledge of international/emerging market pharmaceutical regulations/guidelines.
- Strong collaboration/interpersonal skills; ability to build connections with global/regional/country stakeholders.
- Prior experience as a Regulatory Lead for a marketing application in a global market.
- Relevant regulatory affairs experience focused on international/emerging markets (typically 5 years total; 3+ years in international/emerging markets preferred).
- Bachelor’s degree in a scientific discipline (advanced degree preferred).
- Ability to travel up to 10% (domestic and international).
- The Associate Director, International Regulatory Affairs develops regulatory strategies with multi-functional teams and partners and ensures International Regulatory Requirements for assigned products are complete.
- Coordinates day-to-day preparation of regulatory submissions and creates regulatory submission documents compliant with International Regulatory Requirements.
- Co-leads meetings with International Health Authorities with the International Regulatory Affairs Lead.
Key Responsibilities
- Align and coordinate with Global Multi-functional Team, International Business Unit, Alliance Management, Regional, and Country leads.
- Prepare regulatory dossiers with technical, preclinical, and clinical data for regulatory approvals.
- Direct activities of and interact with contract research organizations and/or distribution partners for dossier preparation.
- Maintain archival records of submissions and health authority contacts; ensure compliance with company policies and train partners as needed.
- Coordinate responses to health authority questions/inquiries; ensure regulatory maintenance submissions (e.g., Renewals, Annual Reports) are completed on schedule.
- Communicate with health authorities (phone, virtual, in-person).
- Present data clearly and succinctly to support regulatory review.
- Coordinate regulatory review and preparation of documents from all company areas.
- Work with Global Liaisons on submission content, strategy, and timelines.
- Advise development teams on unique scientific/regulatory requirements in targeted regions.
- Review submission materials for timeliness, accuracy, completeness, and regulatory standards compliance.
- Manage creation/review/submission of Orphan Designations, Priority Review Applications, GMP Certifications, HA Meeting Requests, and Marketing Authorizations; evaluate requirements for approval and commercialization.
- Provide regulatory strategies for marketing/life-cycle applications (and may support clinical trial applications/expanded access programs).
- Research international regulations/guidance and recommend impacts to project teams.
Qualifications
- Strong knowledge of international/emerging market pharmaceutical regulations/guidelines.
- Strong collaboration/interpersonal skills; ability to build connections with global/regional/country stakeholders.
- Prior experience as a Regulatory Lead for a marketing application in a global market.
- Relevant regulatory affairs experience focused on international/emerging markets (typically 5 years total; 3+ years in international/emerging markets preferred).
- Bachelor’s degree in a scientific discipline (advanced degree preferred).
- Ability to travel up to 10% (domestic and international).